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Thread: Rytmonorm 150 mg tablets

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    Default Rytmonorm 150 mg tablets


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    Indications and Usage for Propafenone

    Propafenone hydrochloride tablets are indicated to:

    • prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease.
    • prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease.
    • treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.

    Usage Considerations:

    • The use of Propafenone hydrochloride tablets in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use Propafenone hydrochloride tablets to control ventricular rate during AF.
    • Some patients with atrial flutter treated with Propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
    • The use of Propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated.
    • Because of the proarrhythmic effects of Propafenone hydrochloride tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
    • The effect of Propafenone on mortality has not been determined

    Warnings and Precautions

    Proarrhythmic Effects

    Propafenone has caused new or worsened arrhythmias. Such proarrhythmic effects include sudden death and life-threatening ventricular arrhythmias such as ventricular fibrillation, ventricular tachycardia, asystole and torsade de pointes. It may also worsen premature ventricular contractions or supraventricular arrhythmias, and it may prolong the QT interval. It is therefore essential that each patient given Propafenone hydrochloride tablets be evaluated electrocardiographically prior to and during therapy to determine whether the response to Propafenone hydrochloride tablets supports continued treatment. Because Propafenone prolongs the QRS interval in the electrocardiogram, changes in the QT interval are difficult to interpret .
    In a U.S. uncontrolled, open label, multicenter trial in patients with symptomatic supraventricular tachycardia (SVT), 1.9% (9/474) of these patients experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) during the study. However, in 4 of the 9 patients, the ventricular tachycardia was of atrial origin. Six of the nine patients that developed ventricular arrhythmias did so within 14 days of onset of therapy. About 2.3% (11/474) of all patients had a recurrence of SVT during the study which could have been a change in the patients' arrhythmia behavior or could represent a proarrhythmic event. Case reports in patients treated with Propafenone for atrial fibrillation/flutter have included increased premature ventricular contractions (PVCs), VT, VF, torsade de pointes, asystole, and death.
    Overall in clinical trials with Propafenone hydrochloride tablets (which included patients treated for ventricular arrhythmias, atrial fibrillation/flutter, and PSVT), 4.7% of all patients had new or worsened ventricular arrhythmia possibly representing a proarrhythmic event (0.7% was an increase in PVCs; 4.0% a worsening, or new appearance, of VT or VF). Of the patients who had worsening of VT (4%), 92% had a history of VT and/or VT/VF, 71% had coronary artery disease, and 68% had a prior myocardial infarction. The incidence of proarrhythmia in patients with less serious or benign arrhythmias, which include patients with an increase in frequency of PVCs, was 1.6%. Although most proarrhythmic events occurred during the first week of therapy, late events also were seen and the CAST study suggests that an increased risk of proarrhythmia is present throughout treatment.
    In a study of sustained-release Propafenone, there were too few deaths to assess the long term risk to patients. There were 5 deaths, 3 in the pooled Propafenone hydrochloride tablets sustained-release group (0.8%) and 2 in the placebo group (1.6%). In the overall pooled Propafenone hydrochloride tablets sustained-release and Propafenone hydrochloride tablets immediate-release database of 8 studies, the mortality rate was 2.5% per year on Propafenone and 4.0% per year on placebo. Concurrent use of Propafenone with other antiarrhythmic agents has not been well studied.

    Unmasking Brugada Syndrome

    Brugada Syndrome may be unmasked after exposure to Propafenone hydrochloride tablets. Perform an ECG after initiation of Propafenone hydrochloride tablets, and discontinue the drug if changes are suggestive of Brugada Syndrome .

    Use with Drugs that Prolong the QT Interval and Antiarrhythmic Agents

    The use of Propafenone hydrochloride tablets in conjunction with other drugs that prolong the QT interval has not been extensively studied. Such drugs may include many antiarrhythmics, some phenothiazines, tricyclic antidepressants, and oral macrolides. Withhold Class IA and III antiarrhythmic agents for at least 5 half-lives prior to dosing with Propafenone hydrochloride tablets. Avoid the use of Propafenone with Class IA and III antiarrhythmic agents (including quinidine and amiodarone). There is only limited experience with the concomitant use of Class IB or IC antiarrhythmics.

    Drug Interactions: Simultaneous Use with Inhibitors of Cytochrome P450 Isoenzymes 2D6 and 3A4

    Propafenone is metabolized by CYP2D6, CYP3A4, and CYP1A2 isoenzymes. Approximately 6% of Caucasians in the U.S. population are naturally deficient in CYP2D6 activity and to a somewhat lesser extent in other demographic groups. Drugs that inhibit these CYP pathways (such as desipramine, paroxetine, ritonavir, sertraline for CYP2D6; ketoconazole, erythromycin, saquinavir, and grapefruit juice for CYP3A4; and amiodarone and tobacco smoke for CYP1A2) can be expected to cause increased plasma levels of Propafenone.
    Increased exposure to Propafenone may lead to cardiac arrhythmias and exaggerated beta-adrenergic blocking activity. Because of its metabolism, the combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition in users of Propafenone is potentially hazardous. Therefore, avoid simultaneous use of Propafenone hydrochloride tablets with both a CYP2D6 inhibitor and a CYP3A4 inhibitor.

    Use in Patients with a History of Heart Failure

    Propafenone exerts a negative inotropic activity on the myocardium as well as beta blockade effects and may provoke overt heart failure.
    In clinical trial experience with Propafenone hydrochloride tablets, new or worsened congestive heart failure (CHF) has been reported in 3.7% of patients with ventricular arrhythmia; of those 0.9% were considered probably or definitely related to Propafenone HCl. Of the patients with CHF probably related to Propafenone, 80% had preexisting heart failure and 85% had coronary artery disease. CHF attributable to Propafenone HCl developed rarely (< 0.2%) in ventricular arrhythmia patients who had no previous history of CHF. CHF occurred in 1.9% of patients studied with PAF or PSVT.
    In a U.S. trial of Propafenone hydrochloride tablets sustained-release in patients with symptomatic AF, heart failure was reported in 4 (1.0%) patients receiving Propafenone hydrochloride tablets sustained-release (all doses), compared to 1 (0.8%) patient receiving placebo.

    Conduction Disturbances

    Propafenone slows atrioventricular conduction and may also cause dose-related first degree AV block. Average PR interval prolongation and increases in QRS duration are also dose-related. Do not give Propafenone to patients with atrioventricular and intraventricular conduction defects in the absence of a pacemaker .
    The incidence of first degree, second degree, and third degree AV block observed in 2,127 ventricular arrhythmia patients was 2.5%, 0.6%, and 0.2%, respectively. Development of second or third degree AV block requires a reduction in dosage or discontinuation of Propafenone HCl. Bundle branch block (1.2%) and intraventricular conduction delay (1.1%) have been reported in patients receiving Propafenone. Bradycardia has also been reported (1.5%). Experience in patients with sick sinus node syndrome is limited and these patients should not be treated with Propafenone.
    In a U.S. trial in 523 patients with a history of symptomatic AF treated with Propafenone hydrochloride tablets sustained-release, sinus bradycardia (rate <50 beats/min) was reported with the same frequency with Propafenone hydrochloride tablets sustained-release and placebo.

    Effects on Pacemaker Threshold

    Propafenone may alter both pacing and sensing thresholds of implanted pacemakers and defibrillators. During and after therapy, monitor and re-program these devices accordingly.


    Agranulocytosis has been reported in patients receiving Propafenone. Generally, the agranulocytosis occurred within the first 2 months of Propafenone therapy and upon discontinuation of therapy, the white count usually normalized by 14 days. Unexplained fever or decrease in white cell count, particularly during the initial 3 months of therapy, warrant consideration of possible agranulocytosis or granulocytopenia. Instruct patients to report promptly any signs of infection such as fever, sore throat, or chills.

    Use in Patients with Hepatic Dysfunction

    Propafenone is highly metabolized by the liver. Severe liver dysfunction increases the bioavailability of Propafenone to approximately 70% compared to 3 to 40% in patients with normal liver function. In 8 patients with moderate to severe liver disease, the mean half-life was approximately 9 hours. Increased bioavailability of Propafenone in these patients may result in excessive accumulation. Carefully monitor patients with impaired hepatic function for excessive pharmacological effects .

    Use in Patients with Renal Dysfunction

    Approximately 50% of Propafenone metabolites are excreted in the urine following administration of Propafenone hydrochloride tablets.
    In patients with impaired renal function, monitor for signs of overdosage .

    Use in Patients with Myasthenia Gravis

    Exacerbation of myasthenia gravis has been reported during Propafenone therapy.

    Elevated ANA Titers

    Positive ANA titers have been reported in patients receiving Propafenone. They have been reversible upon cessation of treatment and may disappear even in the face of continued Propafenone therapy. These laboratory findings were usually not associated with clinical symptoms, but there is one published case of drug-induced lupus erythematosis (positive rechallenge); it resolved completely upon discontinuation of therapy. Carefully evaluate patients who develop an abnormal ANA test and, if persistent or worsening elevation of ANA titers is detected, consider discontinuing therapy.

    Impaired Spermatogenesis

    Reversible disorders of spermatogenesis have been demonstrated in monkeys, dogs and rabbits after high dose intravenous administration of Propafenone. Evaluation of the effects of short-term Propafenone hydrochloride tablets administration on spermatogenesis in 11 normal subjects suggested that Propafenone produced a reversible, short-term drop (within normal range) in sperm count.

    Adverse Reactions

    Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    Adverse reactions associated with Propafenone hydrochloride tablets occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of patients treated with Propafenone hydrochloride tablets have discontinued treatment because of adverse reactions.
    Adverse reactions reported for > 1.5% of 474 SVT patients who received Propafenone hydrochloride tablets in U.S. clinical trials are presented in Table 1 by incidence and percent discontinuation, reported to the nearest percent.

    Adverse reactions reported for ≥ 1% of 2,127 ventricular arrhythmia patients who received Propafenone in U.S. clinical trials were evaluated by daily dose. The most common adverse reactions appeared dose-related (but note that most patients spent more time at the larger doses), especially dizziness, nausea and/or vomiting, unusual taste, constipation, and blurred vision. Some less common reactions may also have been dose-related such as first degree AV block, congestive heart failure, dyspepsia, and weakness. Other adverse reactions included rash, syncope, chest pain, abdominal pain, ataxia, and hypotension.In controlled trials in patients with ventricular arrhythmia, the most common reactions reported for Propafenone hydrochloride tablets and more frequent than on placebo were unusual taste, dizziness, first degree AV block, intraventricular conduction delay, nausea and/or vomiting, and constipation. Headache was relatively common also, but was not increased compared to placebo. Other reactions reported more frequently than on placebo or comparator and not already reported elsewhere included anxiety, angina, second degree AV block, bundle branch block, loss of balance, congestive heart failure, and dyspepsia.
    In addition, the following adverse reactions were reported less frequently than 1% either in clinical trials or in marketing experience. Causality and relationship to Propafenone therapy cannot necessarily be judged from these events.
    Cardiovascular System: Atrial flutter, AV dissociation, cardiac arrest, flushing, hot flashes, sick sinus syndrome, sinus pause or arrest, supraventricular tachycardia.
    Nervous System: Abnormal dreams, abnormal speech, abnormal vision, confusion, depression, memory loss, numbness, paresthesias, psychosis/mania, seizures (0.3%), tinnitus, unusual smell sensation, vertigo.
    Gastrointestinal: Cholestasis, elevated liver enzymes (alkaline phosphatase, serum transaminases), gastroenteritis, hepatitis.
    Hematologic: Agranulocytosis, anemia, bruising, granulocytopenia, leukopenia, purpura, thrombocytopenia.
    Other: Alopecia, eye irritation, impotence, increased glucose, positive ANA (0.7%), muscle cramps, muscle weakness, nephrotic syndrome, pain, pruritus.

    Postmarketing Experience

    The following adverse reactions have been identified during post-approval use of Propafenone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Gastrointestinal: A number of patients with liver abnormalities associated with Propafenone therapy have been reported in post-marketing experience. Some appeared due to hepatocellular injury, some were cholestatic and some showed a mixed picture. Some of these reports were simply discovered through clinical chemistries, others because of clinical symptoms including fulminant hepatitis and death. One case was rechallenged with a positive outcome.
    Blood and Lymphatic System: Increased bleeding time
    Immune System: lupus erythematosis
    Nervous System: Apnea, coma
    Renal and Urinary: Hyponatremia/inappropriate ADH secretion, kidney failure

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